Germ Cell Tumor
Conditions
Keywords
Germ Cell Tumor, Refractory Germ Cell Tumors, Cisplatin plus Epirubicin Salvage Chemotherapy
Brief summary
This study proposes to evaluate the combination of cisplatin plus epirubicin in patients with refractory germ cell tumor not amendable to cure with surgery or standard platinum salvage chemotherapy. This regimen will be used in eligible patients after progression on ECOG Study E39897.
Detailed description
To determine the feasibility and toxicity of combining epirubicin to fixed does cisplatin; to determine the partial and complete response rate and duration of remission; to determine the toxicity; to ascertain the potential for greater than 12 month continuous disease-free survival and, therefore, potential curability.
Interventions
DRUGCisplatin plus Epirubicin
Sponsors
Indiana University
Indiana University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* histologic or serologic proof of metastatic germ cell neoplasm(gonadal or extragonadal primary) w/ disease not amenable to cure with either surgery or chemotherapy. Pts w/ seminoma & non-seminoma are eligible, as are women w/ ovarian germ cell tumors. * Must have failed initial cisplatin combination therapy administered w/ curative intent. In addition, pts should have failed and demonstrated progressive disease following the administration of at least one salvage regimen for advanced germ cell neoplasms unless they have primary mediastinal nonseminomatous germ cell tumor, or are considered to be a late relapse (\>2 yrs since becoming a complete response). * Pts must have adequate system function (WBC\>/= 4,000 & plts \>/=100,000; SGOT \</=4x normal; bilirubin \</=2.0; serum crt \</=2.5) obtained \</= 4 wks prior to entry. * ECOG performance status of 0,1, or 2. * Pts must be at least 3 weeks post major surgery, radiotherapy, or chemotherapy, and have recovered from all toxicity. *
Exclusion criteria
* Active, unresolved infection and/or are receiving concurrent treatment w/ parenteral antibiotics. \*Eligible after antibiotics have been discontinued for at least 7 days. * Pregnant or lactating * Progression w/in 4 wks of lst course of cisplatin combination chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the feasibility and toxicity of combining epirubicin to fixed dose cisplatin | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the partial and complete response rate and duration of remission | — |
Countries
United States
Outcome results
None listed